Course Title:	Advanced Concepts in Oncologic Product Development
Course Details
Course Description: This course is designed to cover oncologic clinical trials from Phase I through Phase IV with discussions of relevant design, ethical and regulatory issues, as well as results of complex trials for both cytotoxic and non-cytotoxic agents. Operational and resource issues relating to clinical trial management will be discussed by experts in clinical oncology research.¿ Chemoprevention, angiogenesis inhibitors, new imaging approaches and an overview of human cancer biology with discussions of specific cancer types, clinical features, and current therapeutics will be described and discussed.
Course Title:	Advanced Good Clinical Practices
Course Details
Course Description: This course is the next step beyond basic Good Clinical Practices training.  GCP auditing techniques and strategies will be the focus.  The course provides in-depth, application-oriented training delivered by faculty who have extensive experience in the GCP arena.
Course Title:	Basic Training Course in Biologics Development
Course Details
Course Description: This course will provide an overview of the processes and problems common in Biological Development. The course will provide participants with an understanding of decision points in the development of new biotechnology medicines from the initial identification of a potential therapeutic or vaccine candidate to post-approval monitoring. The course will focus on the decisions that need to be made throughout the drug development process and the criteria influencing these decisions.
Course Title:	Basic Training Course in Clinical Monitoring
Course Details
Course Description: The goal of this training program is to provide an overview of clinical monitoring in the context of the overall drug development process, FDA regulations, and ICH guidelines for Good Clinical Practices.
Course Title:	Basic Training Course in Drug Development
Course Details
Course Description: Our most popular program! This course provides an introduction to the processes and challenges common to all new development projects, including new chemical entities (NCEs) and biologically derived therapeutic products. Basic drug development steps and ideal characteristics of a development candidate will be described in detail Regulatory requirements and the product label from the US and Global perspectives will be discussed. Interactive workshops will follow the development of a drug from discovery to product label development.
Course Title:	Cancer: Introduction to Oncologic Product Development
Course Details
Course Description: The course will provide an overview of human cancer biology with discussions of specific cancer types, clinical features, current therapeutics, and illustrative case presentations. Specific discussions will be devoted to the rapidly evolving topics of oncogenes, tumor growth factors and use of biological response modifying agents.  Regulatory considerations in trial designs, quality of life issues and statistical considerations are also covered. Intermediate and Advanced Concepts in Oncologic Development are NOW AVAILABLE AS IN-HOUSE PROGRAMS. Please visit their listing in this section for more details.
Course Title:	Cardiovascular and Metabolic Diseases
Course Details
Course Description: NEW COURSE! This course will provide an overview of cardiovascular and metabolic diseases and new advances in drug development.  Topics will include basic anatomy and physiology associated with hypertension, coronary disease, heart attack, and heart failure; coronary and peripheral artery disease, thrombosis and anticoagulation and cardiac arrhythmia. In addition, cardiovascular clinical trial methodology will be discussed. Medical treatments of dyslipidemias and lipidosis; atheroma, atherosclerosis and peripheral arterial disease will also be covered from both clinical and drug development perspectives. Additional topics as per the client’s need will be available: Diabetes: Epidemiology and Pathologies Metabolic Syndrome Coagulation Defects, Coagulopathies and Embolic Disorders Major Cardiovascular Studies and their Conclusions
Course Title:	Clinical Investigator Training Program
Course Details
Course Description: This blended educational program combines On-Line and On-Site Group Training modules to provide a foundational training for physicians and study staff who desire to become Clinical Research Investigators in clinical trials. The live session focuses on the main concepts of conducting clinical research trials including understanding the protocol, planning, enrolling subjects, daily operational aspects of clinical trial conduct, organizational tips, resource planning ideas, financial implications, timeline concerns, and regulatory implications. Group sessions for investigators and coordinators will focus on details particular to those roles such as responsibilities to the sponsors, regulatory, and patients. Participants will be enrolled in the On-Line course “GCPs for the Clinical Research Team,” which provides a foundation of GCPs for the clinical investigators, and can be taken before or after the live session.
Course Title:	Enhanced Clinical Monitoring Techniques and Approches
Course Details
Course Description: This course addresses clinical trial management issues and skills needed to effectively conduct clinical trials in the fast-paced drug development industry. The course presents key factors to consider in the operational aspects of clinical trial conduct, organizational tips, resource planning ideas, timeline concerns, regulatory implications, communications, and team-building.
Course Title:	Good Clinical Practices
Course Details
Course Description: This course will provide attendees with a background in Good Clinical Practices (GCPs) as applied to clinical trials currently conducted worldwide. This course will emphasize GCP requirements and quality assurance functions for clinical trials from several perspectives including those of the sponsor-monitor and their Quality Assurance (QA) groups, institutional review boards (IRB), clinical investigators, and regulatory authorities, (e.g., FDA).
Course Title:	Good Documentation Practices
Course Details
Course Description: This course will provide attendees with a background in Good Documentation Practices (GDPs) as applied to pharmaceutical research. This course will emphasize GDP requirements, responsibilities, standards and regulatory perspectives (e.g., FDA).
Course Title:	Good Laboratory Practices
Course Details
Course Description: This course can be tailored to meet your specific GLP training needs¿! This course addresses fundamental regulatory compliance principles relative to the Food and Drug Administrations (FDA) current Good Laboratory Practice (GLP) regulations. Participants will become acquainted with the history and development of the GLPs, roles and responsibilities of key staff members, the development of SOPs, and considerations for laboratory facilities and equipment. Issues concerning raw data documentation, Part 11, computer validation, training documentation and FDA current issues will also be discussed.
Course Title:	International Regulatory Affairs
Course Details
Course Description: This workshop will provide particpants with an overview of the basic laws, guidelines and regulations governing the development and registration of prescription pharmaceuticals outside of the United States. The emphasis will be on the European Union, Canada, Asia/Pacific but will also include brief information on Japan, Latin America, Southeast Asia, Austrailia and New Zealand.
Course Title:	Introduction to Pharmacology
Course Details
Course Description: This course provides an intensive overview of pharmacology, a knowledge of which is critical for both drug discovery and development. The principles of pharmacodynamics and pharmacokinetics are presented followed by and introduction to the autonomic nervous system. A general introduction to selected therapeutic areas is also included (Oncology, Gastrointestinal, Genitourinary, Endocrine, Hematology).
Course Title:	Overview of Pharmacovigilance: New Regulations and Evolving Practices
Course Details
Course Description: This course will focus on introductory concepts of regulatory requirements in drug safety and anticipated changes that will impact the management and handling of safety data. Topics will include MedDRA, basic epidemiological issues, signal detection and risk management. A group workshop and interactive case studies will emphasize decision-making and crisis management.
Course Title:	Overview of the Approval Process for Vaccines: Aspects of Chemistry, Manufacturing & Control (CMC)
Course Details
Course Description: This course provides a discussion of a number of key topics surrounding the chemistry, manufacturing, and controls (CMC) of vaccines, including topics outline in the Common Technical Document (CTD). The topics covered in the course include developing vaccine stability strategies, current recommendations and strategies for the development of cell substrates, the role and development of vaccine potency assays, as well as specific issues for particular classes of vaccines.
Course Title:	Overview of the Regulated Drug Development Process: Opportunities and Requirements
Course Details
Course Description: This program will provide a comprehensive training program on the development process of safe and effective biopharmaceutical agents in order to facilitate the development of a coherent workforce of product development teams (PDTs) empowered to effectively plan, execute and manage the development of these agents within the current global regulatory environment.
Course Title:	Preparing for an FDA Inspection
Course Details
Course Description: This course will describe the necessary steps in preparing for an FDA Site Inspection. Key topics will include current inspection issues, differences in inspections in the US and Europe, handling inspections and preparing for inspections. A mock Site Audit will be conducted as a practical exercise, followed by a debriefing of the inspection findings
Course Title:	Project Management and Leadership Strategies for Pharmaceutical Scientists
Course Details
Course Description: This course will focus on improving the leadership skills of project leaders and mid-level line managers who work in an environment that requires collaboration in order to be successful. The training will utilize an analytical model of leadership that is readily accepted by technically oriented people and allows participants to accurately identify leadership success requirements in a variety of company-specific situations. Topics will include key decisions in the drug development process, organizational options, skills for planning and managing large and small projects, team building, and more effective interaction with regulatory agencies.
Course Title:	Regulation of Marketing and Promotion of Prescription Drugs
Course Details
Course Description: This course addresses the recent developments in, and current interpretations of, the laws, guidelines and regulations governing the marketing and promotion of prescription drugs and biologic agents, and the external perception of pharmaceutical marketing and promotion.
If you are interested in a training program that is not listed, please contact us at In-House Course Manager or (703) 276-0178. PERI welcomes the opportunity to work with you in developing a course to meet your specific educational needs.